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The exploratory study for the efficacy and the safety of rikkunshito on symptoms of upper gastrointestinal tract in the patients with gastroesophageal reflux disease (GERD)

The exploratory study for the efficacy and the safety of rikkunshito on symptoms of upper gastrointestinal tract in the patients with gastroesophageal reflux disease (GERD) - The exploratory study for the efficacy of rikkunshito in the GERD patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003092
Enrollment
100
Registered
2010-01-26
Start date
2008-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD patients

Interventions

Oral administration of rikkunshito (2.5g t.i.d) before meals for 56 days

Sponsors

Chiba University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Selection criterion at enrollment 1) Patients who were diagnosed as having GERD according to endoscopic testing and the score (4 points or more) obtained on the questionnaire for the diagnosis of reflux disease (QUEST) 2) Patients with the upper gastrointestinal symptoms such as abdominal pain or dyspepsia 3) Patients who have signed consent to participate in this research

Exclusion criteria

Exclusion criteria: 1) Patients with severe cardiac failure, acute inflammatory disease or other severe complications 2) Patients who are pregnant, considering pregnancy or lactation 3) Patients with serious disorder in liver, gallbladder, or pancreas 4) Patients with gastrectomy 5) Patients who are intolerant to oral administration 6) Patients who received drugs prohibited for concomitant use during the observation period 7) Patients during treatment by traditional Japanese medicines 8) Patients considered inappropriate by the study investigator

Design outcomes

Primary

MeasureTime frame
Improvement of upper gastrointestinal symptoms in GERD patients

Secondary

MeasureTime frame
1)Improvement of function of esophageal motility 2)Safety of rikkunshito

Countries

Japan

Contacts

Public ContactToru Sato

Chiba University Hospital Department of Endoscopic Diagnostics and Therapeutics

043-226-2329

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026